Details for New Drug Application (NDA): 203870
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The generic ingredient in NORGESTIMATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 203870
Tradename: | NORGESTIMATE AND ETHINYL ESTRADIOL |
Applicant: | Amneal Pharms |
Ingredient: | ethinyl estradiol; norgestimate |
Patents: | 0 |
Suppliers and Packaging for NDA: 203870
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 203870 | ANDA | A-S Medication Solutions | 50090-3239 | 50090-3239-0 | 1 KIT in 1 KIT (50090-3239-0) |
NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 203870 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1607 | 69238-1607-6 | 1 BLISTER PACK in 1 CARTON (69238-1607-6) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | ||||
Approval Date: | Nov 12, 2015 | TE: | RLD: | No |
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